Guidance for Industry on Formal Dispute Resolutions; Appeals Above the Division Level

ICR 201510-0910-005

OMB: 0910-0430

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-10-21
ICR Details
0910-0430 201510-0910-005
Historical Active 201207-0910-008
HHS/FDA CDER
Guidance for Industry on Formal Dispute Resolutions; Appeals Above the Division Level
Extension without change of a currently approved collection   No
Regular
Approved without change 02/23/2016
Retrieve Notice of Action (NOA) 10/21/2015
  Inventory as of this Action Requested Previously Approved
02/28/2019 36 Months From Approved 02/29/2016
32 0 19
256 0 152
0 0 0

This information collection approval request is for an FDA guidance on the process for formally resolving scientific and procedural disputes in the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research that cannot be resolved at the division level. The guidance describes procedures for formally appealing such disputes to the office or center level and for submitting information to assist center officials in resolving the issue(s) presented.

US Code: 21 USC 312.48 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 314.103 Name of Law: FD&C Act
  
None

Not associated with rulemaking

  80 FR 31386 06/02/2015
80 FR 60918 10/08/2015
No

2
IC Title Form No. Form Name
CDER - Requests for Formal Dispute Resolution
CBER - Requests for Formal Dispute Resolution

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 32 19 0 13 0 0
Annual Time Burden (Hours) 256 152 0 104 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
We have adjusted the currently approved burden of 152 hours to 256 hours based on actual receipts over the past 3 years.

$0
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
10/21/2015


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